Canada may delay its enhanced feed ban by Pete Hisey on 6/9/2006 for Meatingplace.com The Canadian government has been slowly working on an enhanced animal feed ban that would eliminate all specified risk materials from all animal feed, just as they are banned from cattle feed, but Wednesday promised to consider requests from the cattle industry to wait and see if the United States publishes a similar enhancement of its feed ban.

Thus far, the Food and Drug Administration has given no indication it would endorse such a move.

Cattle industry proponents asked Agri-Food Canada to delay adoption of an enhanced ban so that Canadian policy "harmonizes" with that of the United States. The Canadian Food Inspection Agency announced two years ago that it planned to issue an updated feed ban that would bar all specified risk materials, condemned cattle, corpses, and other at-risk products from all animal feed, pet food and fertilizers. That standard now appears to be on hold indefinitely.

Last summer, then-FDA commissioner Lester Crawford announced that FDA was about to introduce a ban similar to the Canadian proposal. He resigned three days later, and FDA instead suggested a less-restrictive ban that would simply bar brains, spinal columns and a few other parts from cattle feed on the theory that virtually all infectivity for bovine spongiform encephalopathy could be found in a handful of tissues.

Consumer groups and scientific experts demanded that Canada move ahead rapidly with the suggested ban as is. According to The Calgary Herald, Dr. Neil Cashman of PrioNet Canada, a research network that studies prion diseases, said that the ban "should be instituted as soon as possible." Another speaker, Dr. Linda Detwiler a BSE specialist from the University of Maryland, said that Canada should protect itself, not wait for the United States to issue an enhanced ban.

Between FYs 2002 and 2004, FSIS condemned 680 cattle of all ages due to CNS symptoms. About 357 of these could be classified as adult. We could validate that ONLY 162 were tested for BSE (per APHIS records. ...

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WE interviewed officials at five laboratories that test for rabies. Those officials CONFIRMED THEY ARE NOT REQUIRED TO SUBMIT RABIES-NEGATIVE SAMPLES TO APHIS FOR BSE TESTING. A South Dakota laboratory official said they were not aware they could submit rabies-negative samples to APHIS for BSE testing. A laboratory official in another State said all rabies-negative cases were not submitted to APHIS because BSE was ''NOT ON THEIR RADAR SCREEN." Officials from New York, Wisconsin, TEXAS, and Iowa advised they would NOT submit samples from animals they consider too young. Four of the five States contacted defined this age as 24 months; Wisconsin defined it as 30 months. TEXAS officials also advised that they do not always have sufficient tissue remaining to submit a BSE sample. ...

4. Professor Richard Marsh has recently described an outbreak of TME in whichthe owner routinely fed cattle material (DEAD STOCK) to mink but claimedNEVER to have fed sheep material. This raises a theoretical possibility that sheep(and goats) may not be the only animal reservoir of scrapie-like agents...

For the past several years we have testified about our continuing work regarding adulterated beef product recalls. In July 2004, a Pennsylvania firm initiated a recall of approximately 170,000 pounds of ground beef patties because of mislabeling. Approximately one-fourth of this product was made, in part, from beef trim from Canada which was not eligible for import to the U.S., following the detection of a Canadian cow with BSE.

http://appropriations.house.gov/_files/FongTestimony.pdf

look on page 44 and up here about the Texas cow also;

Rigid Protocols Reduced the Likelihood BSE Could be Detected

APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE.

When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted

The USDA has made a statement, and we are referring all callers to the USDA web site. We have no informationabout the animal being in Texas. CarlaAt 09:44 AM 11/19/2004, you wrote:>Greetings Carla,>>i am getting unsubstantiated claims of this BSE 'inconclusive' cow is from>TEXAS. can you comment on this either way please?>>thank you,>Terry S. Singeltary Sr.>>======================================

our computer department was working on a place holder we could postUSDA's announcement of any results. There are no results to be announced tonightby NVSL, so we are back in a waiting mode and will post the USDA announcementwhen we hear something.At 06:05 PM 11/22/2004, you wrote:>why was the announcement on your TAHC site removed?>>Bovine Spongiform Encephalopathy:>November 22: Press Release title here >>star image More BSE information>>>>terry>>Carla Everett wrote:>>>no confirmation on the U.S.' inconclusive test...>>no confirmation on location of animal.>>>>>>====================================================

Oversight of FSIS Recalls

For the past several years we have testified about our continuing work regarding adulterated beef product recalls. In July 2004, a Pennsylvania firm initiated a recall of approximately 170,000 pounds of ground beef patties because of mislabeling. Approximately one-fourth of this product was made, in part, from beef trim from Canada which was not eligible for import to the U.S., following the detection of a Canadian cow with BSE.

http://appropriations.house.gov/_files/FongTestimony.pdf

look on page 44 and up here about the Texas cow also;

Rigid Protocols Reduced the Likelihood BSE Could be Detected

APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE.

When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted

The USDA has made a statement, and we are referring all callers to the USDA web site. We have no informationabout the animal being in Texas. CarlaAt 09:44 AM 11/19/2004, you wrote:>Greetings Carla,>>i am getting unsubstantiated claims of this BSE 'inconclusive' cow is from>TEXAS. can you comment on this either way please?>>thank you,>Terry S. Singeltary Sr.>>======================================

our computer department was working on a place holder we could postUSDA's announcement of any results. There are no results to be announced tonightby NVSL, so we are back in a waiting mode and will post the USDA announcementwhen we hear something.At 06:05 PM 11/22/2004, you wrote:>why was the announcement on your TAHC site removed?>>Bovine Spongiform Encephalopathy:>November 22: Press Release title here >>star image More BSE information>>>>terry>>Carla Everett wrote:>>>no confirmation on the U.S.' inconclusive test...>>no confirmation on location of animal.>>>>>>====================================================

On June 24, 2005, USDA informed FDA that a cow in Texas tested positive for Bovine Spongiform Encephalopathy (BSE). Information provided by APHIS was that the BSE positive cow was born and raised in a herd in Texas and was approximately 12 years old. The animal was sampled for BSE at a pet food plant in Texas on November 15, 2004, as part of USDAís enhanced surveillance program. The animal was disposed of by incineration and did not enter the human food or animal feed chains. Although the positive animal posed no risk to the animal feed supply, FDA, APHIS, the Texas Animal Health Commission (TAHC), and the Texas Feed and Fertilizer Control Service (TFFCS) conducted a feed investigation with two main objectives. The first objective was to identify all protein sources in the animalís feed history that could potentially have been the source of the BSE agent. The second objective was to verify that cattle leaving the herd after 1997 that were identified by USDA/APHIS as animals of concern (e.g. progeny and feed cohorts), were rendered at facilities in compliance with the regulation (21 CFR 589.2000) that prohibits most mammalian protein in feed for ruminants that became effective August 4, 1997 (herein called BSE/Ruminant Feed rule).

The feed history investigation identified 21 feed products that had been used on the farm since 1990. These feed products were purchased from three retail feed stores and had been manufactured at nine different feed mills. The investigators visited these establishments to collect information on formulations, shipping invoices, and use of ruminant meat and bone meal (MBM) on the premises both pre-1997 feed ban and post-1997 feed ban. This investigation found no feed products used on the farm since 1997 that had been formulated to contain prohibited mammalian protein.

The investigation identified one feed which contained an animal protein source that could not be identified. The investigation also found one feed mill that supplied feed to the farm that had used ruminant MBM in feed formulations for non-ruminant species after the BSE/Ruminant Feed rule went into effect, which is permitted under the rule, and that several feed mills had used ruminant MBM in feeds prior to the feed ban. Although the investigation did not identify a specific feed source as the likely cause of this animalís infection, it is probable that the most likely route of exposure for this animal was consumption of an animal feed containing mammalian protein prior to the implementation of the BSE/Ruminant Feed rule in 1997.

The investigation into the disposition of herd mates from this farm involved visits to nine slaughter plants and eight rendering plants. The investigation found that all rendering plants were operating in compliance with the BSE/ruminant feed ban regulation. A review of the inspection history of each of these rendering firms found no violations.

Background of Investigation:

When notified on June 24, 2005, FDA Headquarters and Dallas District management officials immediately began making contacts with their Federal, State and Local counterparts to plan for and initiate follow-up investigational activities to determine the feed history in this herd and to assure the safety of the animal feed supply by evaluating current and historic compliance with the BSE/ruminant feed ban rule.

APHIS established a joint Incident Command Post and FDA Dallas District staffed this post full time with a Supervisory Investigator charged with coordinating activities between FDA, APHIS, TAHC and TFFCS. Coordination conference calls were set up with all Federal and State agencies involved in the investigation to keep everyone apprised of investigational developments.

Animal Tracing Activities and Renderer Follow-up Inspections:

One of APHISí primary objectives was to identify and trace the animals of interest (animals of interest would include any animals which could have been potential birth cohorts or feed cohorts of the index animal, or potential offspring of the index animal within the two years prior to the positive diagnosis) from the index herd. This objective included the identification of points of sale and ultimately the actual slaughter facilities for animals of interest that left the farm. As the trace information was developed, APHIS shared this information with FDA. Further information on animal of interest identification and tracing can be found in the USDA Texas BSE Final Epidemiology report.

APHIS identified nine slaughter establishments receiving these animals of interest. Eight of the slaughter establishments were located in the State of Texas and one was located in the State of Georgia. Dallas District Investigators notified USDA/FSIS of our plans to visit each slaughter establishment to identify rendering facilities receiving materials from these slaughter establishments during the timeframe they received animals of interest. Dallas District also issued an assignment to Atlanta District to visit and inspect the one slaughter/renderer establishment located in the State of Georgia.

Eight renderers and one protein source broker were identified as receiving materials from these slaughter establishments. Each rendering facility identified was inspected for current compliance with the mammalian protein feed ban rule. Each firmís operations during the period of time of receipt of these animals post 1997 were evaluated from a historical viewpoint and no evidence of noncompliance was detected.

In all, FDA visited nine slaughter facilities, eight rendering facilities and one broker of these materials. All facilities inspected were found to be in compliance with the BSE/ruminant feed ban rule

Feed Investigation:

As information was learned about the index herd, FDA Investigators working with TAHC officials conducted multiple interviews with the producer of the animal regarding possible feeds, feed sources, animal husbandry practices, and other events which may have changed normal feeding practices over the course of the index animalís life in the herd and any other information which may have been helpful in identifying the possible sources of feed for this animal and herd. FDA corroborated this information through interviews at the retail feed supply stores where the producer purchased feeds.

Follow-up at these retail feed supply stores identified 21 possible feed products the producer may have used during the history of the herd. Fifteen purchased feed products were identified, along with hay, native grass, rice straw, soybean meal, milk replacer/colostrum and bagged corn. These products were identified as originating from nine different manufacturers. Each of these manufacturers was inspected by FDA Dallas District and TFFCS Investigators.

Feed manufacturers were located throughout the State of Texas. An assignment was also issued to another FDA District to visit a Corporate Headquarters facility in an effort to review archived feed formulations and labels. During each of these inspections, the firmís current compliance with the BSE/ruminant feed ban rule was evaluated and attempts were made to determine the protein sources used in feeds on the index farm. Many of the feeds investigated were manufactured and used prior to the implementation of the BSE/ruminant feed ban rule in 1997. Feed products of particular interest included any which may have contained a protein source and the primary focus was on identifying any possible mammalian protein source material in those feed products. We found that ruminant feeds that had contained mammalian meat and bone meal (MBM) prior to the BSE/ruminant feed ban rule had been discontinued or reformulated upon the implementation of these rules. There is no regulatory requirement for a feed mill to archive formulations for that length of time, so in those instances where an actual formulation could not be obtained, experienced employees of the firms were interviewed and their recollections recorded.

Of all the feeds in use by the producer since 1997, none were discovered to have contained prohibited material (mammalian protein). Since the age of the index animal was determined to be approximately 12 years, investigating and reconstructing a feed history over such a long period of time is challenging. This ranch is a beef cow-calf operation and minimal feed records were maintained. Due to the nature of this investigation, it is difficult to determine what feeds were in use at specific times and what the formulation of those feeds were at the time they were fed. A feed history was developed through interviews with the producer and other farm personnel since they did not maintain any feed history documentation. Interviews with personnel at retail establishments disclosed incomplete records and cash sales that did not always identify the purchaser. Dallas District investigated any and all feed ingredients that were identified as being fed or potentially fed over the course of the last 15 years of this herdís operation. Feeds discovered during this investigation with potential mammalian protein sources are as below:

One feed, used prior to 1996, before the implementation of the feed ban, was suspected to contain mammalian meat and bone meal, but this could not be confirmed as no formulation records were available.

The producer recalled using a particular feed sporadically during the 1980ís and 1990ís, however, he could not remember the name or manufacturer of the feed and had no records identifying the product. It is not known whether this feed contained an animal protein source. Attempts to identify this feed through interviews with retail sources were unsuccessful.

The producer identified one feed product that has been used since the year 2000 which contains fish meal as a protein source. Further investigation revealed that this product had contained mammalian meat and bone meal prior to 1997, but that it had been reformulated at that time using fish meal to replace the MBM.

A tabular representation of the feed inspection follow-up activities is presented below:

Feed Dates of Use Protein Source Current BSE Inspection BSE Compliance History

[1] Dallas District previously documented one incident of the accidental addition of mammalian protein to a feed that was to be used for cattle at this facility. This incident was isolated to the manufacture of one lot of a custom cattle feed. A cross contamination error resulted in mammalian meat and bone meal being accidentally included in a feed. The error was detected soon after production. The firm acted swiftly in recalling the product and purchasing the animals that had consumed the feed. No products entered the human food or ruminant feed chain.

Dallas District Compliance History with BSE Feed Ban Rules:

Prior to 1997, feed manufacturers were not required to differentiate between protein sources used in ruminant and non-ruminant feeds. For a period of time following the implementation of the BSE/ruminant feed ban rule, some feed manufacturers continued to use both prohibited material and non-prohibited material within the same facility, employing separation and cleanout procedures to minimize cross-contamination. Although the regulations allow this practice, the potential for cross-contamination of ruminant feeds is greater. Most feed mills have found this practice to be difficult and have abandoned this practice.

Since the implementation of the BSE/ruminant feed ban rule in 1997, Dallas District and its State partners have inspected every known or registered feed manufacturer located in the states of Texas, Oklahoma and Arkansas. Further, every rendering operation and feed manufacturer actually processing with prohibited materials has been inspected annually. The compliance rate of the industry has been excellent.

Results:

In total FDA, along with TFFCS, conducted 33 inspections, investigations and interviews of the producer, retail feed establishments, feed manufacturers, corporate headquarters, slaughter facilities, renderers and a protein source broker. The FDA Dallas District follow-up to this incident resulted in the coordination of efforts of multiple Federal and State agencies. This report is the physical output of many hours of research, planning and coordination. All of the inspections conducted confirmed the feed manufacturers and rendering operations to be in compliance with the current BSE/ruminant feed ban rule.

Dallas District conducts annual inspections of all feed mills and rendering facilities who handle, use or produce PM for feed use. Inspections performed since the initiation of the BSE/ruminant feed ban rules in 1997 have confirmed a high degree of industry wide compliance with these important safeguards. The district also routinely coordinates and shares information regarding feed inspections with the TFFCS who are also responsible for the evaluating feed ban compliance in the state of Texas.